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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2012-1804

2. Registrant Information.

Registrant Reference Number: PROSAR Case 1 29860421

Registrant Name (Full Legal Name no abbreviations): Syngenta Canada Inc.

Address: 140 Research Lane, Research Park

City: Guelph

Prov / State: Ontario

Country: Canada

Postal Code: N1G4Z3

3. Select the appropriate subform(s) for the incident.

Human

4. Date registrant was first informed of the incident.

21-APR-12

5. Location of incident.

Country: UNITED STATES

Prov / State: NORTH CAROLINA

6. Date incident was first observed.

16-APR-12

Product Description

7. a) Provide the active ingredient and, if available, the registration number and product name (include all tank mixes). If the product is not registered provide a submission number.

Active(s)

PMRA Registration No.       PMRA Submission No.       EPA Registration No. Unknown

Product Name: Gramoxone (non-specific)

  • Active Ingredient(s)
    • PARAQUAT
      • Unknown

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

10. Site pesticide was applied to (select all that apply).

Site: Agricultural-Outdoor/Agricole-extérieur

Préciser le type: Unknown

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

Exposure occurred upon re-entry into treated field

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Unknown

Subform II: Human Incident Report (A separate form for each person affected)

1. Source of Report.

Other

2. Demographic information of data subject

Sex: Male

Age: >19 <=64 yrs / >19 <=64 ans

3. List all symptoms, using the selections below.

System

  • Nervous and Muscular Systems
    • Symptom - Muscle weakness
    • Symptom - Slurred speech
    • Symptom - Loss of coordination
  • Cardiovascular System
    • Symptom - Stroke
    • Specify - Light stroke

4. How long did the symptoms last?

Unknown / Inconnu

5. Was medical treatment provided? Provide details in question 13.

Yes

6. a) Was the person hospitalized?

Yes

6. b) For how long?

Unknown

7. Exposure scenario

Occupational

8. How did exposure occur? (Select all that apply)

Contact with treated area

What was the activity? Patient walked through the treated field wearing canvas shoes; did not wash off after got product on skin.

9. If the exposure occured during application or re-entry, what protective clothing was worn? (select all that apply)

None

10. Route(s) of exposure.

Skin

11. What was the length of exposure?

Unknown / Inconnu

12. Time between exposure and onset of symptoms.

>24 hrs <=3 days / >24 h <=3 jours

13. Provide any additional details about the incident (eg. description of the frequency and severity of the symptoms, type of medical treatment, results from medical tests, outcome of the incident, amount of pesticide exposed to, etc.)

Case 1-29860421 Human 1-HS0YE: The reporter, a family member, notified the registrant on 04/21/12 of her fathers exposure to an herbicide containing the active ingredient Paraquat. According to the reporter, her father had sprayed the product about one week prior to the call. He had applied the product at a dilution of 6 ounces to one gallon of water. At some unspecified time after application, the patient had then walked through the field wearing some canvas shoes. He did not wash off after he got the product on his skin. On 04/16/12 the patient developed some difficulty walking (legs buckling) and by the time of the call was exhibiting some slurred speech. The reporter stated that the patient had been to the hospital where blood work had been run; no definitive diagnosis had been established though a stroke was on the list of rule-outs. The patients sense of muscle weakness persisted (could not hold himself up). The patients skin had not been damaged by dermal contact with the herbicide. During the 04/21/12 call it was discussed that the patients symptoms were inconsistent with a dermal exposure to the product. Systemic toxicity to the product would be expected to manifest with damage to the lungs, kidneys and liver. Neurologic signs would not be expected unless the patients liver values were markedly abnormal on blood work. A recommendation was made to continue working with the doctors to identify an underlying cause for the patients symptoms. A follow-up call to the reporter on 04/28/12 revealed that the patient was at home again and was doing fine. He had been diagnosed as having suffered a light stroke. The physicians on the case did not believe the patients symptoms were related to the product.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.